Teva's Innovative Migraine Drug Fremanezumab Lands in Guangdong-Hong Kong-Macao Greater Bay Area Under 'Pilot Policy for Hong Kong/Macao Medicines and Medical Devices'

Riding the "Pilot Program" Wave

ShanghaiJuly 8, 2023PR Newswire -- Recently, Teva's innovative migraine drug Fremanezumab has been authorized by the Guangdong Provincial Drug Administration to land in the Guangdong-Hong Kong-Macao Greater Bay Area, taking advantage of the "Hong Kong-Macao Medicine and Device Connect" policy. In July8Recently, the first patient has already used this innovative drug, which has not yet been approved for marketing in China, at the initially piloted Guangzhou United Family Hospital. The availability of Remanezumab in the Greater Bay Area enriches the options for preventive treatment of migraine within the region, bringing hope to migraine patients for improving their quality of life.

To facilitate the rapid entry of innovative drugs and medical devices into mainland China and better meet the medical needs of Chinese patients, in 2020, the "Work Plan for the Innovation and Development of Pharmaceutical and Medical Device Regulation in the Guangdong-Hong Kong-Macao Greater Bay Area" (referred to as the "Hong Kong-Macao Drug and Medical Device Access Policy") was officially introduced and further implemented across the nine mainland cities of the Greater Bay Area. According to the policy, eligible medical institutions within the Greater Bay Area can use pharmaceuticals and medical devices that have already been marketed in Hong Kong and Macao in accordance with regulations. This innovative measure provides residents of Hong Kong, Macao, and the Greater Bay Area with access to medical treatments and devices that are converging across the three regions, significantly enhancing the sense of gain, happiness, and security for residents of the three areas.

Migraine is a common neurological disease and the second leading cause of human functional impairment globally, which can directly or indirectly increase the social disease burden and pressure on healthcare systems.^[1], also severely impacting patients in various aspects such as work, life, and social interactions. Worldwide, the total number of migraine patients exceeds 1 billion.^[2]The annual prevalence of migraine in China's population aged 18-65 is 9.3%, with an estimated hundreds of millions of migraine patients nationwide.^[3]

Rimegepant is a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide (CGRP) ligand and blocks both α- and β-CGRP subtypes from binding to the receptor. It is indicated for the preventive treatment of migraine in adult patients who experience migraine on at least four days per month, significantly reducing the frequency of migraine attacks. It is currently the only CGRP monoclonal antibody offering flexible dosing options of once every three months (675mg) or once monthly (225mg) via subcutaneous injection, providing convenient clinical use while offering differentiated treatment options that help improve patient adherence to therapy.

Mr. Huang Diren, General Manager of Teva Greater China, stated that the successful launch of Teva's global innovative drugs in the Greater Bay Area demonstrates the country's firm determination to promote the integrated development of healthcare in the Guangdong-Hong Kong-Macao Greater Bay Area, actively introduce innovative drugs to fill treatment gaps, and continuously bring benefits to patients. Teva will also leverage the advantages of China's pharmaceutical industry policies, adhere to a patient-centered approach, and fulfill its long-term commitment of "In China, For China" with practical actions to benefit more patients in China.